Clinical Research Coordinator (CRC) - Louisville, Kentucky

Clinical Research Coordinator (CRC)

The Clinical Research Coordinator (CRC) is responsible for the day-to-day coordination and operational execution of clinical trials conducted within outpatient healthcare settings. The CRC ensures that clinical trials are conducted in accordance with ICH Good Clinical Practice (GCP), FDA regulations, Institutional Review Board (IRB) requirements, Sponsor protocols, and Internal Standard Operating Procedures (SOPs). The CRC serves as the primary operational liaison between study participants, the Principal Investigator (PI), sponsors or Contract Research Organizations (CROs), and internal leadership. The role focuses on ensuring patient safety, regulatory compliance, data integrity, and successful study execution.

The Clinical Research Coordinator reports to operational leadership within the research program. Clinical oversight is provided by the Site Principal Investigator (PI).

Assist with the preparation and activation of clinical trials at assigned healthcare sites. Responsibilities include reviewing study protocols and investigator brochures, assisting with site feasibility assessments, preparing regulatory binders and study documentation, coordinating site initiation visits, ensuring required equipment and study supplies are available, assisting with IRB submissions and regulatory documentation, and coordinating staff protocol training.

Identify and recruit eligible study participants from the site's patient population. Responsibilities include conducting electronic health record (EHR) pre-screening, collaborating with clinical staff to identify potential participants, coordinating with providers to approach eligible patients, explaining study participation requirements, and scheduling screening and enrollment visits.

Assist the Principal Investigator in ensuring that participants fully understand the study, risks and benefits are clearly explained, written informed consent is obtained prior to any study procedures, and all consent documentation is completed and maintained in accordance with regulatory standards.

Coordinate all participant study visits in accordance with study protocols. Responsibilities include scheduling visits per protocol requirements, conducting protocol-required assessments, collecting clinical data, recording vital signs and medical history updates, administering study questionnaires, and ensuring protocol adherence.

Responsible for proper collection, processing, and shipment of biological samples. Responsibilities include processing blood and urine samples, ensuring proper labeling and documentation, preparing shipments according to sponsor laboratory requirements, and maintaining specimen tracking logs.

Ensure that all study data is accurate, complete, and properly documented. Responsibilities include maintaining source documentation, completing Case Report Forms (CRFs) or electronic data capture (EDC) entries, resolving sponsor data queries, and maintaining regulatory binders and essential documents.

Monitor participant safety throughout the study. Responsibilities include monitoring participants for adverse events or side effects, reporting adverse events to the Principal Investigator, ensuring timely reporting to sponsors and IRBs, and maintaining safety documentation.

Serve as the operational point of contact for sponsors and CROs. Responsibilities include participating in monitoring visits, preparing documentation for audits and inspections, responding to sponsor queries, and providing updates on study progress.

Ensure all study activities meet regulatory and quality standards. Responsibilities include maintaining audit readiness, ensuring protocol compliance, following internal standard operating procedures, and supporting internal quality reviews.

Maintain required certifications and stay current with clinical research standards. Required certifications include Good Clinical Practice (GCP), CPR Certification, Human Subjects Protection training (CITI or equivalent), and continuing education is encouraged.

Required Qualifications include a Bachelor's degree in health sciences, nursing, biology, public health, or related field, minimum of 2 years of clinical research experience required, experience working in healthcare or clinical environments, knowledge of clinical research regulations and Good Clinical Practice (GCP), and bilingual (English and Spanish) is a plus.